Description
Verification and Validation Expert in Drug Delivery DevicesFor our client, a recognized company pioneer in the medical devices industry in Switzerland, we are currently looking for a V&V Expert. This project will take place ASAP until December 2015, with the strong possibility of an extension.
Your role:
Verification and Validation Expert leads and manages the End to End test activities related to Medical Drug Delivery Devices to ensure that the final product meet the intended use.
- Define Verification and Validation strategy for Drug Delivery Devices
- Defining the End-to-End System Test Requirements of projects ensuring traceability and testing of all Design Inputs and critical product features
- Review & approve supplier test plans, protocols and reports
- Develop and execute medical device system verification and validation protocols and scripts
- Setup a Defect and Test management tool
- Plan and implement quality assurance and quality control for all test activities related to a project
- Manage all test activities related to a project in term of resources, timing, costs, quality and risk
- Generate verification and validation report summaries and Known anomalies issues
- Communicate effectively with clients and team members, at all levels of the organization to solve complex project business, clinical, and technical challenges, using written and verbal communication
Who you are:
- Masters' degree (or equivalent) in Mechanical engineering or Electronic engineering
- Training to software development life cycle, preferably in the medical device domain (21 CFR 820, IEC 62304, FDA software guidelines ISO 13485 and ISO 11608)
- Minimum of 10 years' experience in V&V of complex Medical device development including electronic and mechanical elements
- Experience in working within a regulated medical device development environment, particularly based on the FDA Quality System Regulation and ISO 13485.
- Excellent interpersonal skills and team spirited with the ability to resolve conflicts and motivate others
- Leadership skills and ability to secure commitment from other stakeholders
- Excellent communication skills to lead with Business Partner and Supplier
- Knowledge of Medical drug delivery devices with embedded software is a plus
- Fluent in English, knowledge of French or / and German is a plus
Should this role be of interest for you, please contact Nicolas Vicari at Real Staffing on or